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U.S. Department of Health and Human Services

Medical Devices

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Letter to PAS Investigators

To:  Clinical Investigators

Subject:  Participation in FDA-mandated Post-Approval Studies

 

Dear Clinical Investigator:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) is issuing this letter to request your support, as a clinical investigator, for the conduct of FDA-mandated Post-Approval Studies.

The CDRH approves medical devices for marketing in the US. When warranted, CDRH may require device manufacturers to conduct post-approval studies to help monitor the safety, effectiveness, and reliability of a medical device for its intended use. Mandated post-approval studies can yield valuable data regarding medical device performance for clinicians, manufacturers, and public health agencies like FDA.

You, as a clinical investigator, are indispensable to the conduct of FDA-mandated post-approval medical device studies. Without the active support and participation of the community of clinical investigators, the considerable benefits of these studies simply cannot be realized.

We are confident that the joint efforts of manufacturers, clinical investigators, and CDRH can result in the conduct of Post-Approval Studies that will yield significant public health benefits. We sincerely appreciate your continued support in assisting FDA to promote and protect public health by ensuring the safety and effectiveness of marketed devices.

If you have questions regarding the post-approval studies, please contact Nicole Jones, Post-Approval Studies Manger at nicoles.jones@fda.hhs.gov or 301-796-6062.

 

Sincerely yours,

 

Danica Marinac-Dabic, M.D., Ph.D.
Director, Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration